Status:
COMPLETED
Clinical Stabilization of Hypercapnia: NIPPV v HVNI
Lead Sponsor:
Vapotherm, Inc.
Collaborating Sponsors:
Erlanger Baroness Hospital
The Cooper Health System
Conditions:
Hypercapnic Respiratory Failure
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will evaluate the ability of High Velocity Nasal Insufflation \[HVNI\] to effect ventilation and related physiologic responses in hypercapnic patients when compared to noninvasive positive ...
Detailed Description
The overall objective of this randomized study is to evaluate the efficacy of HVNI, in comparison to NIPPV, to clinically stabilize and provide respiratory therapy to patients who have COPD with moder...
Eligibility Criteria
Inclusion
- Adults, 18 years or older with a known or suspected diagnosis of COPD
- Presentation with acute hypercapnic respiratory failure
- Moderate to Severe patient baseline hypercarbia/hypercapnia, defined as a baseline PCO2 of 60 mmHg or higher
- Venous pH of 7.0 - 7.35
Exclusion
- Severe metabolic derangements (e.g. suspected drug overdose, mixed acid/base disorder)
- Need for airway protection
- Primary condition of Congestive Heart Failure
- Need for emergent intubation
- Pneumonia diagnosis with significant infiltrate on chest x-ray that is clinically correlated with pneumonia
- Inability to provide informed consent
- Pregnancy
- Known contraindication to perform procedures listed, or therapies described in the protocol
- Respiratory arrest or significant respiratory depression on presentation
- Significant nasal occlusion either unilateral or bilateral
- Absence of spontaneous respiration or known contraindication to HVNI
- Extreme agitation or uncooperativeness that would hinder either arm of randomized therapy
- Determined by the clinician to be sufficiently unstable or unsuitable for this study
Key Trial Info
Start Date :
November 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2023
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04709562
Start Date
November 11 2020
End Date
June 22 2023
Last Update
August 9 2024
Active Locations (7)
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1
Valley Presbyterian Hospital
Los Angeles, California, United States, 91405
2
Dignity Health - St. John's Regional Medical Center
Oxnard, California, United States, 93030
3
George Washington University Hospital
Washington D.C., District of Columbia, United States, 20037
4
University of Maryland
Baltimore, Maryland, United States, 21201